The National Medical Products Administration (NMPA) and the National Health Commission (NHC) have jointly issued a notification aimed at enhancing the regulation of etomidate and modafinil. This follows last month’s announcement from the NMPA and other bureaus regarding the adjustment of the narcotics and psychotropic substances catalog, which downgraded modafinil to a Category II psychotropic drug. The latest document introduces new management regulations for these substances.
New Requirements for Etomidate Manufacturers
Under the new regulations, manufacturers producing etomidate raw materials must apply for designated production qualifications with their provincial drug regulatory departments, in line with existing regulations. They are also required to submit their 2023 production plans. Registrants of etomidate raw materials must adhere strictly to drug registration management regulations when updating labels and instructions. Effective March 1, 2024, all manufactured and imported etomidate raw materials must feature specified identification on their labels and instructions. Previously produced and imported etomidate raw materials can continue to circulate and be utilized within their validity periods.
Starting October 1, 2023, enterprises lacking designated production qualifications and production plans are prohibited from producing etomidate raw materials. Additionally, the production of etomidate formulations cannot be outsourced. Pharmaceutical companies intending to use etomidate raw materials for drug formulations must submit an annual demand plan to their respective provincial drug regulatory departments and procure from designated production or wholesale enterprises. Enterprises without qualifications for Class II psychotropic drugs are barred from purchasing etomidate raw materials. Existing inventories must be registered with local drug supervision authorities and sold in compliance with regulations. Furthermore, the development of etomidate raw materials and related formulations requires approval documents from the NMPA for experimental research. All transactions involving etomidate raw materials—including purchase, mailing, transportation, and import/export—must comply with the relevant regulations.
Modafinil Under Increased Scrutiny
Regarding modafinil, the new regulations designate it as a key product for monitoring drug abuse. As of October 1, 2023, the purchase, storage, and sale of modafinil by corporate headquarters, retail outlets, and drug retail chains, as well as its procurement and use by medical institutions, must adhere to the relevant regulations governing Class II psychotropic drugs.-Fineline Info & Tech
